Tolerance of an Oral Nutritional Supplement(ONS)

NCT ID: NCT01782456

Last Updated: 2013-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2013-04-30

Brief Summary

The objective of this study is to capture information on gastrointestinal tolerance (GI) of an oral nutritional supplement containing a new protein blend in healthy children aged ≥ 3 to ≤ 10 years.

Conditions

Gastro-Intestinal Tolerance

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Study Oral Nutritional Supplement

2 servings per day of a complete and balanced, ready-to-drink oral nutritional supplement with a new protein blend.

Group Type: EXPERIMENTAL

Study Oral Nutritional Supplement

Intervention Type: OTHER

Supplement contains a new protein mix consisting of a blend of milk, soy, and pea protein.

Interventions

Study Oral Nutritional Supplement

Supplement contains a new protein mix consisting of a blend of milk, soy, and pea protein.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age ≥ 3 and ≤ 10 years of age
• Healthy and not suffering from any physical disability.
• Height-for-age and BMI-for-age between the 5th and the 95th percentile as well as a weight-for-age between the 5th and the 85th percentile
• Consumption of 2 servings/day of the investigational product for 7 consecutive days
• Willingness to follow the study procedures and record the data in the diary and complete any forms or assessment as needed throughout the study
• Agreement to not consume a nutritional product that is not study product during the study period

Exclusion Criteria

• History of an acute or chronic condition that may affect feeding habits or nutritional status
• Medications or nutritional supplements, taken on a daily basis for more than 2 weeks during the past month prior to screening visit that may profoundly affect feeding habits or nutritional status
• Clinically significant nutritional deficiency requiring specific treatment
• Acute/chronic condition requiring medical treatment which may include hospitalization such as diabetes or stress induced hyperglycemia, dialysis treatment, inflammatory bowel disease, pancreatitis, autoimmune disease or immunodeficiency, celiac disease, cystic fibrosis, active tuberculosis, malformation of the gastrointestinal tract or gastroesophageal reflux disease
• History of constipation
• Allergy or intolerance to any ingredient in the study product
• Gastrointestinal infection or acute diarrhea at the time of study start
• Hepatitis B or C, or HIV, or malignancy
• Congenital cardiac defects
• Antibiotic therapy within last 2 weeks of start of study
• Dysphagia, aspiration risk, difficulty in swallowing due to acquired/congenital abnormalities

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Abbott Nutrition

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer Williams, MPH

Role: STUDY_CHAIR

Abbott Nutrition

Locations

Radiant Research, Inc.

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

AL09

Identifier Type: -

Identifier Source: org_study_id